TB Treatment Support Tool Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes (TB-TST)

April 17, 2024 updated by: Institute for Clinical Effectiveness and Health Policy

TB Treatment Support Tools: Refinement and Evaluation of an Interactive Mobile App and Direct Adherence Monitoring on TB Treatment Outcomes

The overall goal of this study is to conduct a Randomized Clinical Trial (RCT) to evaluate a tuberculosis treatment support tool (TB-TST), a cellular phone app developed using user-centered design principles and a paper-based drug metabolite urine test strip modified for home use for testing the presence of isoniazid drug metabolites in urine to directly monitor adherence to treatment, to improve treatment outcomes for patients with TB receiving self-administered treatment (SAT).

Poor medication adherence to TB regimens, along with challenges in monitoring patients and returning them to treatment, are important contributing factors to poor outcomes and the development of drug resistance. With advances and proliferation of mobile technology platforms, there is substantial interest in the possible use of mobile health (mHealth) interventions to address these challenges. Of the mHealth approaches under investigation for TB adherence monitoring, drug metabolite testing has been identified as the most promising, ethical, and accurate, and the least intrusive and stigmatizing strategy compared to other mobile solutions, yet its potential remains largely unexplored. Additionally, mobile applications (apps) may provide personalized treatment supervision, increase patients' self-management and improve patient-provider communication by offering more advanced functionalities for patient support and monitoring.

The existing version of the TB-TST app offers education on TB and its treatment, communication with a care-coordinator, tracks treatment adherence (both by self-reporting and direct metabolite test strip images), self-reports treatment side-effects, and retains patient's "diary" notes. This proposal builds on preliminary work to: 1) Refine the TB-TST intervention based on pilot study findings and apply principles of user-centered design; 2) Evaluate the impact of the TB-TST on treatment outcomes compared to usual care; 3) Assess patient and provider perceptions of the facilitators and barriers to implementation of the TB-TST and synthesize lessons learned with stakeholders and policy makers. Primary outcome will be treatment success. Secondary outcomes will include: treatment default rates, self-reported adherence, technology use and usability. Findings have broader implications not only for TB adherence but disease management more generally and will improve our understanding of how to support patients facing challenging treatment regimens

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Tuberculosis remains one of the top ten causes of death globally despite it being largely curable. Patients face many challenges to adhere to treatment and mobile health (mHealth) interventions may address these challenges and support patients to complete their treatment. We will improve an interactive intervention based on the combined input from patients and TB experts and evaluate the intervention's impact on treatment outcomes in a randomized clinical trial. Findings have broader implications not only for TB adherence but disease management more generally and will improve our understanding of how to support patients in challenging treatment regimens.

Study Type

Interventional

Enrollment (Actual)

555

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sarah Iribarren, RN PhD
  • Phone Number: 206 543 5211
  • Email: sjiribar@uw.edu

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1414
        • IECS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must be at least 16 years old,
  • have a new diagnosis of drug-susceptible TB,
  • First treatment
  • have regular access to a smartphone, and
  • be able to operate the phone or have someone able to assist.

Exclusion Criteria:

  • Children up to 15 years old
  • Retreatment (default or previous treatment failure)
  • Patients who are severely ill (i.e., requiring hospitalization)
  • Patients who reside in the same household with another study participant
  • Inability to operate a smartphone
  • Illiteracy (inability to read and write)
  • Patients with known drug resistance
  • Patients with known HIV co-infection will be excluded because their care is managed separately.
  • Screened patients who do not meet study eligibility will have specific screening data (including gender, age and reason for exclusion) entered into the study database to examine reasons for exclusion and feasibility of enrollment criteria.

Case definition: Patients at least 16 year old with TB confirmed by smear-positive sputum or diagnosis of pulmonary TB based on radiological findings and clinical signs and symptoms but with negative sputum smear. The diagnosis may be confirmed by other methods, such as, MGIT960, BACTEC 9000 or MB Bact, nucleic acid amplification (PCR) or ELISA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention: TB treatment assistant
Patients receiving instructions to use phone application
Other: TB treatment assistant
Cell phone app to support self administered treatment and monitor adherence
Other Names:
  • TB-TST (Treatment Support Tools)
No Intervention: Control
Patients receiving instructions for usual care self administered treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success
Time Frame: 6 months
Completion of treatment and or cure
6 months
Treatment default
Time Frame: 6 months
Abandonment of treatment for at least 2 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical Effectiveness and Health Policy

Collaborators

University of Washington

Investigators

  • Principal Investigator: Fernando A Rubinstein, MD MPH, Institute for Clinical Effectiveness and Health Policy
  • Principal Investigator: Sarah Iribarren, RN PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12112019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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